Enzon Announces PEG-INTRON(tm) Receives FDA Approval for
the Treatment of Chronic Hepatitis C; First Pegylated Interferon
Approved for Marketing in the United States
PISCATAWAY, N.J.--(BUSINESS WIRE)--Jan. 22, 2001--Enzon, Inc.
(NASDAQ:ENZN) announced today that Schering-Plough Corporation
(NYSE:SGP) has received U.S. Food and Drug Administration
(FDA) approval for PEG-INTRON(TM) (peginterferon alfa-2b)
Powder for Injection as once-weekly monotherapy for the treatment
of chronic hepatitis C in patients not previously treated
with alpha interferon who have compensated liver disease and
are at least 18 years of age.
PEG-INTRON is the first and only pegylated interferon approved
for marketing in the United States. The product is expected
to be available nationwide in early February 2001.
PEG-INTRON is a longer acting form of Schering-Plough Corporation's
INTRON(R) A that uses proprietary PEG technology developed
by Enzon. Under the Company's licensing agreement with Schering-Plough
Corporation, Enzon is entitled to royalties on worldwide sales
of PEG-INTRON and milestone payments. This approval triggers
the final milestone payment of $2 million under the licensing
"While combination therapy with alpha interferon and
ribavirin is a recognized standard of care for chronic hepatitis
C, PEG-INTRON monotherapy offers an alternative to patients
whom combination therapy may be a contraindication or who
are intolerant of this therapy," said John G. McHutchison,
M.D., medical director, liver transplantation, division of
gastroenterology and hepatology, Scripps Clinic and Research
Foundation, La Jolla, Calif. "As the first pegylated
interferon product approved for marketing, PEG-INTRON provides
a valuable addition to the therapies available to physicians
for treating this serious disease," Dr. McHutchison said.
"We are pleased that our PEG technology will play such
an important role in the treatment of patients afflicted with
this virus," said Peter G. Tombros, Enzon's president
and chief executive officer. "Schering-Plough's rapid
advancement of this product to the market offers evidence
of the benefits that our PEG technology may provide to compounds
with delivery limitations."
PEG-INTRON is administered subcutaneously once weekly for
one year. The dose should be administered on the same day
of each week and may be self-administered by patients.
The safety and efficacy of PEG-INTRON has been demonstrated
in a randomized, controlled clinical study involving 1,219
adult patients with chronic hepatitis C who were not previously
treated with alpha interferon. The study compared PEG-INTRON
(0.5, 1.0 or 1.5 mcg/kg) administered subcutaneously once
weekly to Schering-Plough's INTRON(R) A (interferon alfa-2b,
recombinant) Injection (3 MIU) administered subcutaneously
three times weekly. Patients were treated for 48 weeks and
were followed for 24 weeks post-treatment. In the study, patients
receiving the 1.0 mcg/kg dose of PEG-INTRON achieved a 24
percent treatment response rate of sustained virologic response
and ALT(1) normalization as compared to a 12 percent treatment
response rate in patients receiving INTRON A. The safety and
efficacy of PEG-INTRON in combination with ribavirin have
not been established.
Nearly all study patients experienced one or more adverse
events. The incidence of serious adverse events was similar
(about 12 percent) in all treatment groups. The most common
adverse events associated with PEG-INTRON were "flu-like"
symptoms, which occurred in approximately 50 percent of patients;
injection site irritation or inflammation, seen in 47 percent
of patients; and depression, seen in 29 percent of patients.
Alpha interferons, including PEG-INTRON, cause or aggravate
fatal or life-threatening neuropsychiatric, autoimmune, ischemic
and infectious disorders. Patients should be monitored
closely with periodic clinical and laboratory evaluations.
Patients with persistently severe or worsening signs or symptoms
of these conditions should be withdrawn from therapy.
In many but not all cases these disorders resolve after stopping
PEG-INTRON, recombinant interferon alfa-2b linked to a 12,000
dalton polyethylene glycol (PEG) molecule, is a once-weekly
product designed to optimize the balance between antiviral
activity and elimination half-life. Schering-Plough
holds an exclusive worldwide license to PEG-INTRON.
Schering-Plough markets the product as PEGINTRON(TM) in the
European Union, where it received marketing approval in May
2000. INTRON A is a recombinant version of naturally
occurring alpha interferon, which has been shown to exert
both antiviral and immunomodulatory effects. Schering-Plough
markets INTRON A, the world's largest-selling alpha interferon,
for 16 major antiviral and anticancer indications worldwide.
Some 4 million Americans are infected with the hepatitis C
virus (HCV) and approximately 70 percent of infected patients
go on to develop chronic liver disease, according to the Centers
for Disease Control and Prevention (CDC). Hepatitis C infection
contributes to the deaths of an estimated 8,000 to 10,000
Americans each year. This toll is expected to triple by the
year 2010 and exceed the number of annual deaths due to AIDS,
according to the CDC. The CDC has reported that HCV-associated
end-stage liver disease is the most frequent indication for
liver transplantation among adults.
Enzon is a biopharmaceutical company developing advanced therapeutics
for life-threatening diseases through the application of its
proprietary drug delivery and targeting technologies, PEG
Modification, Pro Drug/Transport technology and Single-Chain
Antigen-Binding (SCA(R)) protein technology.> In addition
to PEG-INTRON, the Company also has two other approved products,
ONCASPAR(R) for Acute Lymphoblastic Leukemia (ALL) and ADAGEN(R)
a treatment for a form of Severe Combined Immunodeficiency
Disease (SCID), commonly known as the "Bubble Boy Disease".
In addition to three FDA approved products, Enzon has several
products in various stages of clinical development by itself
and with partners, including additional indications for PEG-INTRON
with Schering-Plough. PEG-INTRON is also in Phase III clinical
trials being conducted by Schering-Plough for the treatment
of malignant melanoma and chronic myelogenous leukemia. Enzon
develops and markets products on its own and through strategic
alliances, which in addition to Schering-Plough Corporation,
include Alexion Pharmaceuticals, Inc., Baxter Healthcare Corporation,
Bristol-Myers Squibb Company, Eli Lilly & Company, and
Except for the historical information herein, the matters
discussed in this news release include forward-looking statements
that may involve a number of risks and uncertainties. Actual
results may vary significantly based upon a number of factors
which are described in the Company's Form 10-K, Form 10-Q's
and Form 8-K on file with the SEC, including without limitation,
risks in obtaining and maintaining regulatory approval for
the Company's products and expanded indications for such products,
market acceptance of and continuing demand for Enzon's products
and the impact of competitive products and pricing. The forward-looking
statements included in this news release provide the information
included in such statements as of the date of this news release
and the Company disclaims any duty to update any of such statements.
This release is also available at enzon.com
(1) ALT: alanine aminotransferase, an enzyme that indicates
ongoing liver inflammation.
When the Peg-Intron trials were over, several months ago,
I began receiving calls from people who had been involved.
These were the sickest group from which I have heard. On average
they had viral loads 3 times higher than when they started.
They suffered the most severe disabling effects, far worse
than interferon. People told me that they had to move their
beds down stairs because they could not climb the stairs,
they expressed the need to hire people to come into their
homes to care for them because they could not even comb their
own hair. As the study says, some of the effects may
continue even after you stop. I have heard from several people
that they feel they are permently damaged from the stuff.
As most of you know I am opposed to this "cure"
from the dark ages, but let me reassure that this stuff is
absolute poison and I urge you to avoid it.
It is my option that it was created to help maintain market
share, as Schering-Plough's patent on interferon has run out
and other companies are making it.
Try it if you feel the need, when it fails, I will be here
to help you recover from it and Hep C.
Other Related Messages:
Interferons do NOT work (NIAID Study)
- April 27, 2003
Center of Biologics Evaluation and Research review of PEG-Intron
- March 31, 2003
Lost in Maine
January 8th, 2003
October 23, 2002
Problems Associated with Toxicity
July 27, 2002
February 5, 2001
companies suppressing or manipulating the results...
Jan 07, 2001
impact of Interferon on Hepatitis C patients
January 1, 2001